MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; ARTIC GEL PADS

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 08/18/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that customer was reaching out about any skin issues that can occur while using the arctic gel pads.Customer stated that they called to gather some information about preventing pressure injury with the artic sun pads.Nurse had two pressure injuries from the pads , and it came up in a discussion whether they could place a mepilex lite under the borders of the pads.And mss was not sure though if this would interfere with the device.Event occurred prior to starting this position.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿improper pad design - e.G.Location of connectors, manifold¿.It was unknown whether the device had met relevant specifications.The product was used for diagnostic and treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd was unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that customer was reaching out about any skin issues that can occur while using the arctic gel pads.Customer stated that they called to gather some information about preventing pressure injury with the artic sun pads.Nurse had two pressure injuries from the pads , and it came up in a discussion whether they could place a mepilex lite under the borders of the pads.And mss was not sure though if this would interfere with the device.Event occurred prior to starting this position.Medical intervention was unknown.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: ARTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15307845
• MDR Text Key: 298773889
• Report Number: 1018233-2022-06707
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 08/28/2022
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other